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Single-Patient EA Policies/Criteria

Patients with severe or life-threatening conditions may need medical treatments that are not yet approved or accessible in their country. For these cases, pharmaceutical companies have a procurement mechanism for physicians referred to as Expanded Access, Compassionate Use, Early Access or Emergency Use. Zenith Epigenetics’ Expanded Access Program is committed to providing eligible patients access to our investigational medicines when standard therapies have failed or are not tolerated, they are ineligible for clinical studies, and/or no other treatments are available. Information about Zenith Epigenetics’ clinical trials can be found at clinicaltrials.gov.

The policy outlined below provides the general guidelines that Zenith Epigenetics will follow for its Expanded Access Program. This ensures that requests for access to our investigational medicines are evaluated and processed in compliance with relevant legal and regulatory requirements.
Policy

Enrolling in a clinical trial is the safest way to access an investigational treatment, but in many cases, patients are not eligible to participate in a clinical trial. In such instances, Zenith Epigenetics can provide access to our investigational medications through the US Food and Drug Administration (FDA) and the US government under Expanded Access Programs (EAP) and Right to Try (RTT) laws, respectively. Zenith Epigenetics may provide access through our Expanded Access Program by emailing EAP@zenithepigenetics.com but each case must meet the following conditions:

Patients must meet the following criteria:
Have a NUT carcinoma diagnosis by NUTM1 immunohistochemistry (IHC) and subsequent fluorescence in situ hybridization (FISH) or ribonucleic acid (RNA) sequencing to identify the fusion partner.
Have no suitable treatment alternatives.
Cannot participate in a clinical trial.
Other serious or life-threatening conditions will be considered but there must be data showing the potential benefits outweigh the risks.
Providing access should not interfere with any of Zenith Epigenetics’ clinical development programs required for regulatory approval and commercialization. This includes:
Disrupting clinical trials or participant enrollment.
Causing drug supply issues
The treating physician must be licensed and qualified to:
Safely administer the investigational medicine.
Follow local regulations for expanded access.
Monitor and report adverse events as required by local law and company policy.
For US patients, access can only be granted through single patient IND filed by the treating physician and/or medical institution.
For international patients (ex-US), access can only be granted based on local laws and regulations for a single patient

Zenith Epigenetics will confirm receipt of Expanded Access Program inquiries within five (5) business days. Inquiries will be evaluated and approved on a case-by-case basis. Medications will be provided free of charge but requesting institutions will need to cover courier costs. Zenith Epigenetics may close the program at any time for various regulatory or logistical reasons. This policy is also subject to change and its posting does not guarantee access of any medicine to any individual patient.


 

Available Therapies via Single-Patient EA

ZEN003694 is available for NUT carcinoma.

Single-Patient EA Policies/Criteria

Zhejiang DTRM Biopharma Co. Ltd. is an oncology-focused Biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. Our development resources are focused on conducting scientific research that evaluates the safety and effectiveness of new medicines for patients with cancer. Our clinical trial programs are the primary way to get access to one of Zhejiang DTRM Biopharma’s investigational medicines. These clinical trials provide the most effective way to assess how our investigational medicines may treat cancer and are used to support regulatory approval. Zhejiang DTRM Biopharma encourages patients to speak with their treating physicians about participating in a clinical trial, when possible. You can find additional information about Zhejiang DTRM Biopharma’s ongoing clinical trials by accessing https://clinicaltrials.gov.
Where enrollment into a clinical trial is not an option, and where all currently available treatment options have been exhausted, an investigational medicine may be provided prior to regulatory approval or commercial availability, under a provision referred to as “Expanded Access” (also commonly called “Compassionate Use”) by the U.S. Food and Drug Administration (“FDA”).
Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy exists. Per FDA, Expanded Access may be appropriate when all of the following apply:
1. A patient has a serious disease or condition, or a patient’s life is immediately threatened by their disease or condition.
2. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
3. Patient enrollment in a clinical trial is not possible.
4. Potential patient benefits justify the potential risks of treatment.
5. Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
As a general policy, Zhejiang DTRM Biopharma will not provide investigational medicines to patients until a dose and schedule has been well established for the agent, preliminary data exists that the agent has some evidence of activity in a particular indication, and the agent is found to be safe as a result of a risk-benefit evaluation.
Zhejiang DTRM Biopharma is not currently making any of its investigational medicines available on an Expanded Access basis prior to regulatory approval anywhere in the world. Zhejiang DTRM Biopharma may reconsider making one or more of its investigational medicines available through an Expanded Access Program in the future. As authorized by the 21st Century Cures Act, Zhejiang DTRM Biopharma may revise this Expanded Access Policy at any time.
If you have additional questions, please speak with your treating physician or contact Zhejiang DTRM Biopharma at dtrm-555fdctablets@dtrmbiopharma.com